GE Healthcare GE Healthcare

February 7,2006

U.S. Nuclear Regulatory Commission Division of Nuclear Materials Safety Region I King of Prussia, PA 19406

RE: Amendment to Material License 29-28341-02MD

Dear S ir/Madame

Please amend license condition 1 1 .A to include the following individuals;

Arlene Lewin, R.Ph Kevin McGuffy, R.Ph

Both individuals are registered pharmacists in the State of New Jersey and authorized nuclear pharmacist with certification in Nuclear Pharmacy from Purdue University. Enclosed are copies of Miss Lewin and Mr. McGuffy certificate, a synopsis of their training received at Purdue, documentation of their experience handling radionuclides and copies of their New Jersey pharmacist licensure letter.

Should you have additional question please feel free to contact me at 973-533-9109.

Sincerely,

q%&~AauL- ose-An B. Duvigneaud, R.Ph

Radiation Safety Officer

General Electric Company 1 Naylon Place Livingston, NJ 07039 U.S.A.

’ PURDUE U N I V E R S I T Y

January 19,2006

Kevin McGuffy GE Healthcare 1 Naylon Place Livingston, NJ 07039

Dear Kevin:

SCHOOL OF PHARMACY AND PHARMACEUTICAL SCIENCES

We are pleased to provide the enclosed certificate to recognize formally your completion of the Nuclear Pharmacy Certificate Program. We enjoyed the brief opportunity to share our knowledge from the world of academia. We wish you the very best for a gratifying and successful professional career.

As you continue on in your career, please do not hesitate to let us know if we can be of any assistance to you - we consider you part of the “Purdue family” and we look forward to hearing from you in the future!

Sincerely,

Steve Piepenbrink, R.Ph., BCNP Director of Nuclear Pharmacy Engagement Division of Nuclear Pharmacy

Division of Nuclear Pharmacy, Department ______. of Industrial and Physical Pharmacy _______ Heine Pharmacy Building, Room 308 575 Stadium Mall Drive B West Lafayette, IN 47907-2091 (765) 494-1441 PP Fax: (765) 496-3367 = URL: www.purdue.edu/nuclearpharmacy

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES*

On-Site 73 26

Name: George Tzortzis

Date(s) of Attendance

I I I I Total I Nuclear Clock Radiation Pharmacy Hours Physics & Certificate of Instru- Program Course mentation

Location of Training

Radiation Protection

Math Radiation Pertaining Biology to Radio- activity

Video- Workbook

On-Site

to a Lecture/Laboratory

Purdue University

A B

150 54

73 26

Purdue University

Column "A" refel

Video- Workbook

150 54

A l B I

TOTAL

Course

Column " B refers to a Supervised Laboratory Experience

iwn of Course Content in Clock Hours

H

56 I 27 I I _ _ _ _ _ ~ _ _ _ _ _ _ _ ~-

0 This form is representative of that which is used to apply for an NRC license amendment for an authorized user. n

iadio- Dharma- zeutical Shemistry

A

25

11

36

36

Qq?LL!(!& Director, Nuclear Pharmacy Certificate Program

Documenting Experience Handling Radioisotopes (Actual Use of Radioisotopes Under the Supervision of an Authorized User)

Name: Kevin McGuffy, RPh.

Isotope

Ba-133

Cr-5 1

Ga-67 In-1 11

CS-137

CO-57

I- 123 1-131 Mo-99 Sr-89 Tc-99m

Xe-133 T1-201

Maximum amount used at one time

150 uCi 170 uCi 300 uCi 10 mCi

300 mCi 10 mCi 20 mCi 150 mCi

18 Ci 10 mCi 18 Ci

300 mCi 700 mCi

Where experience was gained GE Healthcare Livingston, NJ

Duration of Experience (actual clock hrs)

25 25 25 25 50 50 50 50 35 5

200 65 35

Type of use

Key for Type of Use The number or numbers entered ‘Type of Use’ correspond to experience in the following activities:

1. Ordering, receiving and unpacking radioactive materials safely, including performing related radiation surveys.

2. Calibrating dose calibrators, scintillation detectors and survey meters. 3. Calculating, preparing and calibrating patient doses, including the proper use

of radiation shields. 4. Following appropriate internal control procedures to prevent mislabeling

errors. 5. Learning emergency procedures to handle and contain spilled materials safely,

including related procedures for decontamination, surveys and wipe tests. 6. Eluting technetium-99m generator systems, assaying eluate for technetium-

99m and molybdenum-99, and processing the eluate with reagents kits to prepare technetium-99m labeled radiopharmaceuticals.

rlRC FORM 313A 10-2002)

U.S. NUCLEAR REGULATORY COMMISSION

TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT

Mote:

I . Name of Individual, Proposed Authorization (e.g., Radiation Safety Officer), and Applicable Training Requirements

Descriptions of training and experience must contain sufficient detail to match the training and experience criteria in the applicable regulations.

(e.g., 10 CFR 35.50)

APPROVED BY OMB: NO. 3150012( EXPIRES: 10'31'2005

k'fh ?. For Physicians, Podiatrists, Where Licensed

Specialty Board Month and Year Certified Category

Description of Training

tadiation Physics and Instrumentation

[adiation Protection

lathematics Pertaining to the Use nd Measurement of Radioactivity

adiation Biology

hemistry of Byproduct Material for edical Use

THER

C FORM 313A (10-2002)

Location . _

Clock Hours

3F

023

'7"

/ I

Dates of Training

q05

PAGE 1

JRC FORM 313A US. NUCLEAR REGULATORY COMMISSIOr 10-2002) TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

5a. WORK EXPERIENCE WITH RADIATION

Description of Experience

I U

I 5b. SUPERVISED CLINICAL CASE EXPERIENCE

: ,, i

NRC FORM 313A U.S. NUCLEAR REGULATORY COMMISSION (10-2002) TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

5a. WORK EXPERIENCE WITH RADIATION

I 5b. SUPERVISED CLINICAL CASE EXPERIENCE No. of Cases

Involving Personal Radionuclide Type of Use

I

Name of

Individual

A PAGE 2

.

IRC FORM 313A U.S. NUCLEAR REGULATORY COMMISSION IO-2002) TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

6. FORMAL TRAINING (applies t o Medical Physicists and Therapy Physicians)

Degree, Area of Study or

Residency Program

Name of Program and Location with

Corresponding . Materials

License Number

Approved the Program (e.g., Accreditation Council

for Graduate Medical Education) and the Applicable Regulation

Dates

7. RADIATION SAFETY OFFICER --ONE-YEAR FULL-TIME WORK EXPERIENCE

a YES

~ N J A of the RSO for License No.

Completed I-year of full-tme radiation safety experience (in areas identified in item 5a) under supervison

8. MEDICAL PHYSICIST -- ONE-YEAR FULL-TIME TRAlNlNGMlORK EXPERIENCE

a YES Completed I-year of full-time training in therapeutic radiological physics under the supervision of

a N J A who meets requirements for Authorized Medical Physicists; and

3 YES

d N / A modali!y(ies) under the supervision of who meets

Completed I-year of full-time work experience (for areas identified in item 5a) for

modality(ies). - requirements of Authorized Medical Physicists for

9. SUPERVISING INDIVIDUAL -- IDENTIFICATION AND QUALIFICATIONS

he training and experience indicated above was obtained under the supervision of (if more than one supervising individual is eeded to meet requirements in 70 CFR 35, provide the following information for each) :

B.

Authorized Medical Physicist

Radiation Safety Officer Authorized Nuclear Pharmacist &ib

C. Supervisor meets requirements of Part 35, Section(s)

for medical uses in Part 35, Section(s)

E. Materials License Number bpy- 29 -2r341 -ZJMl MI- i0355/ol

4RC FORM 313A 10-2002)

U.S. NUCLEAR REGULATORY COMMISSION

TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

PART II -- PRECEPTOR STATEMENT

Vote: This pad must be completed by the individual's preceptor. I f more than one preceptor is necessary to document experience, obtain a separate precepfor statement from each. This part is nof required fo meet the training requirements in 10 CFR 35.590.

Item 10 must be completed for Nuclear Pharmacists meeting the requirements of 10 CFR Part 35, Subpart J. Preceptors do not have to complete items 1 1 a, 11 b, or the certifying statements for other individuals meeting the requirements of 10 CFR Part 35, Subpart J.

ES

NIA

I O . The individual named in item 1 has satisfactorially completed the training requirements in

10 CFR 35.980 and is competent to independently operate a nuclear pharmacy.

YES 1 la . The individual named in Item 1 has satisfactorily completed the requirements in Part 35, Section(s)

and Paragraph(s)

$3 YES 1 1 b. The individual named in Item 1. is competent to independently function as an authorized

NIA for uses (or units).

12. PRECEPTOR APPROVAL AND CERTIFICATION

I certify the approval of item 10 and certify I am an Authorized Nuclear Pharmacist;

or 3 I certify the approval of items 1 l a and 11 b, and certify I am an Authorized Nuclear Pharmacist;

or J I certify the approval of Items 1 l a and 11 b, and I certify that I meet the requirements of

or equivalent Agreement State requirements to be a preceptor authorized

for the following uses (or units) of byproduct material:

A. Address

GE HEALTHCARE 1 Naylon Place

tfvjngston, NJ 07039 973-533-91 09

B. Materials License Number / l J R t -L4-2834/ - u 2 m

/035/0/

. NAME OF PRECEPTOR (print cleariy)

PAGE 4

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES*

Location of Date(s) of Nuclear Training Attendance Pharmacy

Certificate Program

Name: Arlene Lewin

Total Clock Hours of Course

Video- Workbook

I I I

150 Purdue University

On-Site

Column " A refers to a Lecture/Laboratory Course

HOURS Column "B" refers to a Supervised Laboratory Experience

Break

Radiation Physics & Instru- mentation i 80

lown of Coursc

Radiation Protection 7 56

56

2ontent in Clol

Math Pertaining to Radio- activity

~

24

24

Hours

Radiation Radio- Biology pharma-

ceutical Chemistry

I 36 27

0 This form is representative of that which is used to apply for an NRC license amendment for an authorized user.

Director, Nuclear Pharmacy Certificate Program

Documenting Experience Handling Radioisotopes (Actual Use of Radioisotopes Under the Supervision of an Authorized User)

Name: Arlene Lewin, Rph.

Isotope Maximum amount used at one time

Ba-133

Cr-5 1

Ga-67 In-1 11

CS-137

CO-57

I- 123 1-131 Mo-99 Sr-89 Tc-99m

Xe-133 T1-201

150 uCi 170 uCi 300 uCi 10 mCi

300 mCi 10 mCi 20 mCi 150 mCi

18 Ci 10 mCi 18 Ci

300 mCi 700 mCi

Where experience was gained GE Healthcare Livingston, NJ

Duration of Experience (actual clock hrs)

25 25 25 25 60 45 50 50 30 5

3 00 70 50

Type of use

Key for Type of Use The number or numbers entered ‘Type of Use’ correspond to experience in the following activities:

1. Ordering, receiving and unpacking radioactive materials safely, including performing related radiation surveys.

2. Calibrating dose calibrators, scintillation detectors and survey meters. 3. Calculating, preparing and calibrating patient doses, including the proper use

of radiation shields. 4. Following appropriate internal control procedures to prevent mislabeling

errors. 5. Learning emergency procedures to handle and contain spilled materials safely,

including related procedures for decontamination, surveys and wipe tests. 6. Eluting technetium-99m generator systems, assaying eluate for technetium-

99m and molybdenum-99, and processing the eluate with reagents kits to prepare technetium-99m labeled radiopharmaceuticals.

IRC FORM 313A IO-2002)

U.S. NUCLEAR REGULATORY COMMISSION

TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT

PART I --TRAINING AND EXPERIENCE

APPROVED BY OMB: NO. 3150412C 10/3112005

Vote: Descriptions of training and experience must contain sufficient detail to match the training and experience criteria in the applicable regulations.

Specialty Board

. Name of Individual, Proposed Authorization (e.g., Radiation Safety Officer), and Applicable Training Requirements (e.g., 10 CFR 35.50)

Month and Year Certified Category

I. For Physicians, Podiatrists, Dentists, Pharmacists - State or Territory Where Licensed

3. CERTIFICATION

~-

Stop here when using Board Certification to meet 70 CFR Part 35 training and experience resuirements.

4. DIDACTIC OR CLASSROOM AND LABORATORY TRAINING (optional for Medical Physicists)

Description of Training

tadiation Physics and Instrumentation

!adiation Protection

lathematics Pertaining to the Use nd Measurement of Radioactivity

'adiation Biology

:hemistry of Byproduct Material for ledical Use

)THER

Location Clock Hours

37

Dates of Training

NRC FORM 313A (10-2002) PAGE 1

IRC FORM 313A U.S. NUCLEAR REGULATORY COMMISSION 0-2002) TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

5a. WORK EXPERIENCE WITH RADIATION

Description of Experience

Location and Corresponding

Materials License Number

Name of Supervising Individual(s)

5b. SUPERVISED CLINICAL CASE EXPERIENCE

Corresponding Materials License Radionuclide

NRC FORM 313A U.S. NUCLEAR REGULATORY COMMISSIOh [ 10-2002) TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

5a. WORK EXPERIENCE WITH RADIATION

Radionuclide

Sr 8

5b. SUPERVISED CLINICAL CASE EXPERIENCE

Type of Use No. of Cases

Involving Personal

Participation

Name of

,

PAGE 2

i

IRC FORM 3 1 3 ~ U.S. NUCLEAR REGULATORY COMMlSSlOh 10-2002) TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

Degree, Area of Study or

Residency Program

6. FORMAL TRAINING (applies to Medical Physicists and Therapy Physicians)

Name of Program and Location with

Corresponding Materials

License Number

Approved the Program (e.g., Accreditation Council

for Graduate Medical Education) and the Applicable Regulation

Dates

7. RADIATION SAFETY OFFICER -- ONE-YEAR FULL-TIME WORK EXPERIENCE

ES

iA of the RSO for License No.

Completed I-year of full-tme radiation safety experience (in areas identified in item 5a) under supervison

8. MEDICAL PHYSICIST -- ONE-YEAR FULL-TIME TRAININGWORK EXPERIENCE

YES

@N/A

Completed 1 -year of full-time training in therapeutic radiological physics under the supervision of

who meets requirements for Authorized Medical Physicists; and

ES

/A modality(ies) under the supervision of who meets

Completed I-year of full-time work experience (for areas identified in item 5a) for

requirements of Authorized Medical Physicists for modality(ies).

9. SUPERVISING INDIVIDUAL -- IDENTIFICATION AND QUALIFICATIONS

-he training and experience indicated above was obtained under the supervision of (if more than one supervising individual is reeded to meet requirements in 70 CFR 35, provide the following information for each) :

A. Name of Supervisor 6. Supervisor is:

%t- &NIL l?, DL(iiGdBv,rO Authorized User uthorized Medical Physicist

Radiation Safety Officer uthorized Nuclear Pharmacist

C. Supervisor meets requirements of Part 35, Section(s)

for medical uses in Part 35, Section(s)

E. Materials License Number dRe $24 283Mjul.b dr l03S5/0/

PAGE 3

RC FORM 313A 0-2002)

U.S. NUCLEAR REGULATORY COMMlSSlOh

TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

PART II -- PRECEPTOR STATEMENT

lote: This part must be completed by fhe individual's preceptor. If more than one preceptor is necessary to document experience, obtain a separate preceptor sfatemenf from each. This part is not required to meet the training requirements in IO CFR 35.590.

Item 10 must be completed for Nuclear Pharmacists meeting the requirements of 10 CFR Part 35, Subpart J. Preceptors do not have to complete items 1 1 a, 11 b, or the certifying statements for other individuals meeting the requirements of 10 CFR Part 35, Subpart J.

YES

NIA

IO. The individual named in item 1 has satisfactorially completed the training requirements in

10 CFR 35.980 and is competent to independently operate a nuclear pharmacy.

~~

ES

/A and Paragraph(s)

1 1 a. The individual named in Item 1 has satisfactorily completed the requirements in Part 35, Section(s)

YES

NJA for uses (or units).

1 1 b. The individual named in Item I. is competent to independently function as an authorized

12. PRECEPTOR APPROVAL AND CERTIFICATION

I certify the approval of item 10 and certify I am an Authorized Nuclear Pharmacist;

or 3 I certify the approval of items 1 l a and 11 b, and certify I am an Authorized Nuclear Pharmacist;

or 7 I certify the approval of Items 1 l a and 11 b, and I certify that I meet the requirements of

or equivalent Agreement State requirements to be a preceptor authorized

for the following uses (or units) of byproduct material:

A. Address B. Materials License Number

.

This is to acknowledge the receipt of your letter/application dated

L(7 /k6d , and to inform you that the initial processing which includes an administrative review has been performed.

/&%&w, 2-9- Z ~ q + - ~ Z W d There were no administrative omissions. Your application was assigned to a technical reviewer. Please note that the technical review may identify additional omissions or require additional information.

Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee & Accounts Receivable Branch, who will contact you separately if there is a fee issue involved.

Your action has been assigned Mail Control Number I 3.3 p3/ When calling to inquire about this action, please refer to this control number. You may call us on (610) 337-5398, or 337-5260,

NRC FORM 532 (RI) (6-96)

Sincerely, Licensing Assistance Team Leader